Porcine Extracellular Matrix Nerve Wrap in Neck Dissection for Head and Neck Cancer

NCT07268092 | Suspended DMC FDA Device

• 1 other identifier: HFHS-1901
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

Brief Summary

Perform a preliminary efficacy study using the porcine extracellular matrix nerve wrap (AxoGuard Nerve Protector™, AxoGen Inc., Alachua, FL) to wrap the spinal accessory nerve (SAN) during neck dissections for head and neck cancer as it relates to postoperative shoulder function, both subjectively and objectively.

Conditions

Head and Neck Cancer; Neck Dissection; Postoperative Complications

Keywords

Spinal Accessory Nerve Injury; Shoulder Dysfunction; Head and Neck Cancer; Nerve Compression Syndromes; Postoperative Complications

Outcome Measures

Primary Outcomes (4)

• Change from baseline in shoulder flexion active range of motion (degrees)

  Shoulder flexion active range of motion will be measured using goniometry. A clinically significant decline is defined as a ≥12° decrease compared to preoperative baseline. Unit of Measure: Degrees

  From preoperative baseline assessment up to 12 months post-surgery

• Change from baseline in Quick Disabilities of the Arm, Shoulder, and Hand (QuickDASH) score

  Subjective upper extremity function will be assessed using the QuickDASH questionnaire (0-100 scale, higher scores indicate worse disability). Unit of Measure: Score

  From preoperative baseline assessment up to 12 months post-surgery

• Change from baseline in Neck Dissection Impairment Index (NDII) score

  Subjective shoulder-related quality of life will be assessed using the NDII questionnaire (0-50 scale, higher scores indicate greater impairment). Unit of Measure: Score

  From preoperative baseline assessment up to 12 months post-surgery

• Change from baseline in shoulder abduction active range of motion (degrees

  Shoulder abduction active range of motion will be measured using goniometry. A clinically significant decline is defined as a ≥23° decrease compared to preoperative baseline. Unit of Measure: Degrees

  From preoperative baseline assessment up to 12 months post-surgery

Study Arms (2)

Treatment Arm - Neck dissection with AxoGuard Nerve Protector™

EXPERIMENTAL

Participants undergo neck dissection surgery for head and neck cancer, during which the spinal accessory nerve (SAN) is wrapped with the AxoGuard Nerve Protector™ (porcine extracellular matrix nerve wrap). This intervention aims to improve postoperative shoulder function by protecting and supporting the nerve during healing. Postoperative physical therapy evaluations will be conducted at baseline, immediate post-op, 1, 6, and 12 months.

Device: Porcine Extracellular Matrix Nerve Wrap (AxoGuard Nerve Protector™)

Control Arm - Neck dissection without AxoGuard Nerve Protector™.

NO INTERVENTION

Participants undergo standard neck dissection surgery for head and neck cancer without the application of the AxoGuard Nerve Protector™. Postoperative physical therapy evaluations will be conducted at baseline, immediate post-op, 1, 6, and 12 months to assess shoulder function.

Interventions

Porcine Extracellular Matrix Nerve Wrap (AxoGuard Nerve Protector™) DEVICE

The intervention involves the application of the AxoGuard Nerve Protector™, a nerve wrap derived from porcine extracellular matrix (ECM), to the spinal accessory nerve (SAN) during neck dissection surgery in head and neck cancer patients. The device is designed to protect and support the nerve by preserving the extracellular matrix and creating a favorable environment for nerve healing. This helps prevent inflammation and fibrosis around the nerve, potentially improving postoperative shoulder function. The nerve wrap is applied intraoperatively after dissection but before surgical closure. The study compares this intervention to standard neck dissection without nerve wrapping.

Treatment Arm - Neck dissection with AxoGuard Nerve Protector™

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients at least 18 years old
• Patients with no previous treatment of head and neck cancer
• Patients with no prior neck surgeries
• Patients undergoing level IIA and IIB neck diss

You may not qualify if:

• Patients with previously treated head and neck cancers
• Patients undergoing level V neck dissection
• Patients undergoing bilateral neck dissection
• Patients with previous neck surgery unrelated to head and neck cancer
• Patients allergic to porcine products or with religious/cultural restrictions on porcine products
• Patients unable to consent
• Individuals who are not adults (infants, children, teenagers)
• Pregnant women
• Prisoners

Sponsors & Collaborators

• Henry Ford Health System: lead

Study Sites (1)

Henry Ford Health System

Detroit, Michigan, 48202, United States

Location

MeSH Terms

Conditions

Head and Neck Neoplasms; Postoperative Complications; Accessory Nerve Injuries; Nerve Compression Syndromes

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Accessory Nerve Diseases; Cranial Nerve Diseases; Nervous System Diseases; Cranial Nerve Injuries; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Peripheral Nervous System Diseases; Neuromuscular Diseases

Study Officials

• Samantha Tam, MD

  Henry Ford Health System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice Chair-Otolaryngology • Otolaryngology

Study Record Dates

• First Submitted: July 9, 2025
• First Posted: December 5, 2025
• Study Start: January 25, 2021
• Primary Completion (Estimated): August 12, 2026
• Study Completion (Estimated): August 12, 2026
• Last Updated: December 5, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)